Levels of Visfatin/NAMPT in Human Milk (VISFAMILK)

November 12, 2024 updated by: Paolo Manzoni Study Group

Levels of Visfatin/NAMPT in Human Milk.VISFAMILK

Visfatin, released in maternal milk at different concentrations related to the maternal conditions, could act as a biomarker with a prognostic/predictive value to determine different newborn clinical conditions, particularly the weight loss of the neonate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to analyse a retrospective cohort of well characterized mothers in their post-partum period, and to measure Visfatin levels through collection of maternal milk samples. They will be collected in three different moments after the birth (48 hours, 7 days and 30 days) and Visfatin levels will be analysed through an ELISA kit Adipogen. In parallel, the levels of Visfatin will be evaluated in the maternal plasma/serum collected after 1-2 days postpartum.

Lastly, correlations between Visfatin levels and biological/clinical features of mothers and newborns will be explored.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • BI
      • Ponderano, BI, Italy, 13875
        • Recruiting
        • Ospedale degli Infermi - ASL BI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

30 women, hospitalized after childbirth, with respective healthy, breastfed infants

Description

Inclusion Criteria:

  • Healthy male and female infants born after 37 weeks' gestation who do not have conditions related to congenital abnormalities
  • Maternal hospitalization
  • Acquisition of the informed consent form signed by the patient

Exclusion Criteria:

  • Refusal of the patient to participate in the study
  • Presence of hypogalactia or agalactia in the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visfatin levels
Time Frame: 48 hours, 7 days and 30 days
Visfatin levels in maternal milk samples
48 hours, 7 days and 30 days
Visfatin levels
Time Frame: 1-2 days post-partum
Visfatin levels in maternal plasma/serum
1-2 days post-partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
values of Visfatin
Time Frame: 6 months
correlate the values of Visfatin to different demographic and clinical characteristics of the lactating mothers
6 months
values of Visfatin
Time Frame: 6 months
correlate the values of Visfatin to different biological/clinical features of the newborns; in particular, we will focus attention on the weight loss of the neonate
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paolo Manzoni Study Group

Collaborators

Università degli Studi del Piemonte Orientale Amedeo Avogadro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

April 23, 2025

Study Completion (Estimated)

April 23, 2025

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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